Optical Detection Infiltration/Extravasation in Neonates (ODINE)

NCT05638971 | Completed

• 1 other identifier: 3886
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral intravenous (PIV) therapy is one of the most common invasive procedures performed in hospitals. PIV failures often occur when fluids leak out of the vein into surrounding tissue. This failure is usually called infiltration if the leakage involves non-vesicant solutions or extravasation in case of vesicant solutions. In this clinical study both infiltration and extravasation events are indicated by the term "infiltration". neonatal intensive care unit patients are an high-risk population for infiltration due to their intrinsic characteristic: poor and fragile vein asset, frequent and uncontrolled movements, need for prolonged intravenous drug and fluid administration. Current nursing practice involves regular PIV site assessments for continuous infusions; particular attention is payed to the identification of swelling, pain, redness, warmth, or coolness. As infiltration represents a leading cause of iatrogenic injury, an early identification, an early identification can minimize its consequences. The ivWatch Model 400 is a device that assists medical professionals in monitoring patients for PIV infiltrations using an optical sensor. This device received FDA clearance and European Conformity Mark for use in the adult and pediatric age groups. ivWatch enhanced the Model 400 to support a new disposable electronic sensor (SmartTouch sensor). In this study, the SmartTouch Sensor will be tested in a neonatal population in a NICU setting. The new sensor design includes optical components in the sensor package, similar to a typical pulse oximeter. Primary study objective is to investigate whether the ivWatch SmartTouch sensor may be helpful in early identification of any kind of infiltration, if compared with our current standards of care.

Conditions

Extravasation Injury; Infant, Premature, Diseases

Outcome Measures

Primary Outcomes (1)

• TIME

  How many times the ivWatch detect infiltrations before nurses. The degree of injury is calculated on the Millian scale.

  through study completion, an average of 30 hours

Secondary Outcomes (1)

• TIME 2

  through study completion, an average of 30 hours

Study Arms (1)

Sensor Group

EXPERIMENTAL

The first half sample size Peripheral intravenous canula will be enrolled in a non-alarming group. ivWatch will monitor the Peripheral intravenous canula insertion site collecting data without notifications. The goals of the study on the nonalarming group are: a) to evaluate ivWatch sensitivity to detect infiltration in comparison with nurse standard of care; b) to estimate the difference in terms of time to detection of ivWatch in comparison with nurse standard of care

Device: ivWatch

Interventions

ivWatch DEVICE

The second half sample size PIVC will be enrolled into an alarming group. ivWatch will monitor the PIVC insertion site collecting data and sending visual and auditory notifications of any infiltration. The goals of the study on the alarming group are: a) to estimate the notification rate (the number of detected infiltration in the studied period; b) to evaluate the extension and severity of the detected infiltration at the time of the notification, so to gather if ivWatch is helpful in early diagnosis

Also known as: Sensor Allarm Group

Sensor Group

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Term and pre-term infants;
• birth weight \> 1.5 kg;
• need for continuous IV therapy with an expected duration \> 24 hours.

You may not qualify if:

• birth weight \</= 1.5 kg;
• non continuous IV therapy;
• IV therapy expected duration \</= 24 hours;
• skin disorders.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

FPGemelliIRCCS

Rome, 00168, Italy

Location

Related Publications (2)

• Wallis MC, McGrail M, Webster J, Marsh N, Gowardman J, Playford EG, Rickard CM. Risk factors for peripheral intravenous catheter failure: a multivariate analysis of data from a randomized controlled trial. Infect Control Hosp Epidemiol. 2014 Jan;35(1):63-8. doi: 10.1086/674398. Epub 2013 Dec 2.

  PMID: 24334800 BACKGROUND

• Helm RE, Klausner JD, Klemperer JD, Flint LM, Huang E. Accepted but Unacceptable: Peripheral IV Catheter Failure. J Infus Nurs. 2019 May/Jun;42(3):151-164. doi: 10.1097/NAN.0000000000000326.

  PMID: 30985565 BACKGROUND

MeSH Terms

Conditions

Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 6, 2022
• Study Start: August 1, 2021
• Primary Completion: May 5, 2022
• Study Completion: July 12, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)